DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 have been presented for examination on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 13 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7, 13 and 19 are indefinite for reciting one sided ranges, including “greater than 50 gsm”, “greater than 100 mm” and “greater than 30 ˚C”. The said limitations render the claims indefinite because the ranges encompass indefinite levels that are neither possible nor supported by the specification. For example, greater than 50 gsm, encompasses 1000 gsm, which is not possible and not envisioned by the Applicants. The Specification states “The needled fabrics may have a weight greater than 50 gsm, e.g. in the range 50-100 gsm, or about 80-90 gsm in some examples” (See [0061] of Published version). Thus, the Specification does not provide any support for a weight higher than 100 gsm.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claims are broad and encompass any nonwoven fabric, any carrier layer, any active substance, and binder, etc.
Claims 1, 2 and 8 recite limitations such as “mechanically consolidated”, “needle punching” and “entangled by needle punching” are process steps, which make the claims product-by-process claims. According to MPEP § 2113 [R-1], product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al (US 20210251276) in view of Davis et al (US 20150201642) and Seiler et al (EP 4193849).
Johnson et al teach oral pouched products in the form of a porous pouch defining a cavity containing a composition adapted for oral use, wherein the porous pouch is formed from a fleece material comprising two or more layers, wherein the two or more layers are in direct contact with one another. Also disclosed is a product that includes at least one layer of fleece material and at least one layer of a gel that is in direct contact with the fleece material and methods of forming such pouched products using multi-layered and/or gel-based approaches (See abstract).
Regarding claims 1, 4 and 14, in part, Johnson et al teach a method of providing an oral product with a customized flavor release profile, comprising: selecting a first nonwoven material; selecting a second nonwoven material; incorporating an active ingredient and/or flavorant within one or both of the first and second nonwoven materials; constructing a multi-layered fleece material from the first and second nonwoven materials. The two or more layers comprise an inner layer adjacent to the composition adapted for oral use and an outer layer forming an outer surface of the pouched product, wherein at least one of the inner layer and the outer layer comprises an active ingredient, a flavorant, or both (See [0007]-[0009] and claim 1).
Regarding claims 1-2 and 14, in part, Johnson et al teach a method of preparing pouched products, comprising: combining two or more nonwoven layers to give a fleece material and enclosing a composition adapted for oral use within a porous pouch formed from such fleece material. In some embodiments, a laminated structure is prepared using needle punching, and the laminated structure is subsequently extruded into the fleece material. (See [0010] and claims 11-12).
Regarding claim 3, Johnson et al teach that the composition for oral use has a color associated with it (See [0014], [0042] and [0045]).
Regarding claims 5-6 and 10, Johnson et al teach that in heat bound embodiments, the nonwoven fabric can be formed using a thermoplastic polymer as a binder fiber. The fibers can be in staple form in certain embodiments, but advantageously, the fibers of the nonwoven fabric are in the form of continuous filaments (See [0068], [0063], [0071] and [0141]).
Regarding claim 7, Johnson et al teach that nonwoven fabric can have a basis weight of about 18 gsm to about 80 gsm, or to about 60 gsm (See [0073]).
Regarding claim 8, Johnson et al teach that the stretched polymer fibers are collected as a randomly entangled, self-bonded nonwoven web (See [0066]).
Regarding claim 9, Johnson et al teach an oral pouched product comprising a composition adapted for oral use comprising at least one layer of fleece material and at least one layer of a gel; wherein the gel is in direct contact with the at least one layer of fleece material. wherein the porous pouch comprises an inner surface and an outer surface, and wherein the at least one layer of gel is adhered to the inner surface of the porous pouch. The oral product comprises a first nonwoven material and a second nonwoven material with different properties (See [0011] and claims 15-16 and 19).
Regarding claim 11, Johnson et al teach an oral product comprising an inner layer and wherein the at least one layer of gel is adhered to the outer surface and the gel comprises an active ingredient, a flavorant, or both, and wherein the gel is configured for rapid release or gradual release of the active ingredient, the flavorant, or both (See [0009] and claims 16-17).
Johnson et al lack a specific disclosure on the dimensions of a tablet or strip. These are well known in the art as taught by Davis et al and Seiler et al.
Davis et al teach unwrapped and uncoated chewing gum products exhibiting excellent stability when bulk packaged as loose units (See abstract).
Regarding claims 1 and 11, Davis et al teach a container; and a plurality of elongated chewing gum pellets housed within the container, the elongated chewing gum pellets having a curvilinear shaped surface (See [0009] and claim 1). The chewing gum piece is formatted in a layered structure having two or more layers of chewing gum or gum base or alternating layers of chewing gum and a non-chewing gum confectionery. The said layer of a non-chewing gum confectionery sandwiched between two layers of chewing gum or gum base. The center layer of non-chewing gum confectionery can be exposed on one two, three or four sides of the chewing gum piece (See [0028]-[0029]).
Regarding claim 12, Davis et al teach that the said elongated chewing gum pellet has a shape having a length of about 18 to about 45 mm, a width of about 6 to about 14 mm, and a thickness of about 2 to about 10 mm (See [0023] and claim 11).
Seiler et al teach an oral smokeless product in the form of an oral patch comprising a carrier and an active agent and/or a flavor, wherein the carrier is a fibrous carrier consisting of a water insoluble nonwoven material. Also disclosed is a method for manufacturing the oral smokeless product, the method comprising: providing a nonwoven material; providing a liquid flavor solution comprising flavor, glycerol, alginate or gum acacia, water and optionally food color; applying the liquid flavor solution to the nonwoven material; and optionally- punching out individual oral smokeless products from the nonwoven sheet material (See abstract).
Seiler et al disclose an oral smokeless product wherein the carrier is constituted by a nonwoven laminate material consisting of two or more layers, such as 2 to 5 layers (See [0047], [0076] and claim 11).
Regarding claim 13, Seiler et al teach an oral smokeless product that has an oblong shape with a maximum width of 5 mm to 40 mm, such as 7 mm to 30 mm, a length of 10 mm to 70 mm, and a thickness in the range of from 0.2 mm to 5 mm (See [0077] and [0083]).
Further regarding claim 7, Seiler et al teach that the nonwoven material of the carrier of the oral smokeless product may have a basis weight of 70 g/m2 to 300 g/m2, such as 70 g/m2 to 150 g/m2. The weight of the carrier is the dry weight of the carrier (See [0078]). The product comprises the nonwoven web constituting the carrier and active agents and/or flavors (See [0080]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Davis et al and Seiler et al with that of Johnson et al to arrive at the instant invention. It would have been obvious to do so because all references teach oral products comprising fibers such as nonwoven fibers and one or more active agents for delivery of the active or a flavoring agent to the oral cavity.
More specifically, Johnson et al teach a layered oral dosage form which comprises a gel layer comprising an active agent or a flavorant. It is disclosed that the dosage form may be a multi-layer product comprising a binder and a gel layer and a carrier medium comprising an active agent. Johnson et al also disclose a method of making the said product which includes needle punching and heating the layers and fibers as well as suitable weight range for this layered product. Davis et al also teach a plurality of elongated chewing gum pellets housed within the container, formatted in a layered structure having two or more layers of chewing gum or gum confectionery. Davis et al provide guidance on the dimensions of the said elongated pellets. Seiler et al further teach an oral smokeless product in the form of an oral patch comprising a carrier and an active agent in a nonwoven fiber matrix and in layered structure. Seiler et al also provide guidance on the dimensions of the said patch (strip).
Thus, it would have been obvious to combine the teachings of Davis et al and Seiler et al with that of Johnson et al to arrive at the claimed invention with a reasonable expectation of success as all references disclose an effective oral dosage form in a layered structure and comprising a layer of active agent for the delivery of the said active to the oral cavity of the subject. While Johnson et al do not expressly disclose the dimensions of their dosage form, the prior art such as Davis and Seiler et al provide guidance on the said dimensions and show that it would have been obvious to one of ordinary skill in the art to determine the dimensions based on the need and design of the product and by following the suggestions in the art.
Regarding the length of the strip in claim 13 being equal to or greater than 100 mm, while Seiler et al teach a length of up to 70 mm, it is considered that the person of ordinary skill in the art would have been able to adjust this based on need or design. In this regard the courts have held that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). It is further noted that the length of an oral strip is not a critical limitation of the said dosage form and can easily be decided by routine experimentation.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al (US 20210251276) in view of Seiler et al (EP 4193849) and Mellin et al (WO 2022112085).
Johnson et al and Seiler et al’s teachings are delineated above are incorporated herein.
Johnson et al further teach that the manner in which the fibers or filaments are bound can vary, and include thermal, mechanical and chemical techniques that are selected in part based on the desired characteristics of the final product. In some embodiments, the oriented fibers undergo a heat treatment process in order to bind them together. In heat bound embodiments, the nonwoven fabric can be formed using a thermoplastic polymer as a binder fiber. The thermoplastic polymer can exhibit a melting point in a relatively low range to facilitate heat sealing of the pouch material. For example, the thermoplastic polymer fiber can typically have a melting point of about 200° C. or less, such as about 120° C. or less. Examples of thermoplastic polymers include various polyolefin and polyester materials. For example, the binder fibers can comprise an aliphatic polyester (See [0064] and [0068]).
Johnson et al also teach that the said multi-layered and gel-containing pouched products can be packaged within any suitable inner packaging material and/or outer container (See [0098]).
Johnson et al lack disclosure on some of the claimed method steps for the preparation including mechanical consolidation. These are known in the art as taught by Seiler et al and Mellin et al.
Additionally, Seiler et al teach that several methods may be used to bond together the fibers in the web, also called web consolidation, including mechanical bonding, e.g. needle punching, stitch bonding, hydroentanglement, and chemical bonding. More than one bonding method may be used to consolidate the nonwoven (See [0008]).
Regarding claims 14-20, in part, Seiler et al teach a method for manufacturing the said oral smokeless product comprising: providing a nonwoven carrier material in the form of a coherent nonwoven web or as individual patches of the nonwoven carrier material; providing a liquid flavor solution comprising flavor, a thickening agent such as glycerol, alginate or gum acacia, and water; applying the liquid flavor solution to the nonwoven material and severing individual oral smokeless products from the coherent nonwoven web, such as by cutting or punching (See [0105]-[0106] and claims 21-22).
Mellin et al teach a chewable product for oral delivery of a substance. The chewable product is an essentially homogenous portion of nonwoven fabric impregnated with the substance. The said chewable product may comprise a nonwoven fabric substrate having a matrix of interleaved fibers. The nonwoven fabric substrate may be formed by passing an initial web through a needle loom. The substance may be connected to fibers in the matrix by a binder (See abstract).
Mellin et al teach that the fibers may comprise regenerated cellulose (viscose) fibers, and may optionally include thermoplastic fibers (e.g. polypropylene or the like), and be deposited in a loose layer. The substance (or active agent thereof) may comprise any of smokeless tobacco, nicotine salts, cannabidiol, coffee, tea, flavoring, aspirin, paracetamol, etc. The nonwoven substrate may be shaped in conventional oral dosage forms, e.g. as a tablet, pill or lozenge and may have a cuboidal shape, with a thickness equal to or greater than 0.5 mm, e.g. in the range of 0.5 to 5 mm (See Page 12, 2nd para and Page 7).
Regarding claims 14-20, in part, Mellin et al teach that the matrix of interleaved fibers may preferably be formed by needle punching, which is a mechanical web consolidation technique. It is disclosed that “The method 200 continues with a step 210 of applying the substance to be delivered when a chewable product formed from the nonwoven material is used. As mentioned above, the substance may be applied directly or together with a carrier medium, excipient or binder. The applying step may comprise impregnating the fiber matrix with a slurry of the substance. The fiber matrix may be dipped, sprayed or otherwise coated in order to apply the substance. The method further comprises packaging the plurality of individual portions” (See Page 12 and claim 31).
Mellin et al teach that the nonwoven fabric substrate may comprise staple fibers that are food grade. The nonwoven fibers may comprise a mixture of staple fibers of viscose and thermoplastic fibers. The method may further comprise heating the matrix of interleaved fibers. The heating step acts to improve or strengthen links between the thermoplastic fibers and other fibers in the matrix (See Page 3, last para).
The substance may be applied in any suitable manner, e.g. using any of a roll-to-roll coating process, a printing process, a laminator, a dip-coating unit or a spray unit. For example, the step of applying the substance may comprise dipping the matrix of interleaved fibers in a liquid containing the substance. The method may include a step of removing any excess liquid, e.g. by rolling and/or drying the matrix. In another example, applying the substance may comprise spraying the matrix with a liquid or powder containing the substance. The substance may comprise a carrier medium and an active agent, as discussed above. In this case, the step of applying the substance may comprise binding the carrier medium to the matrix of interleaved fibers.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Mellin et al and Seiler et al with that of Johnson et al to arrive at the instant invention. It would have been obvious to do so because all references teach oral products comprising fibers such as nonwoven fibers and one or more active agents for delivery of the active or a flavoring agent to the oral cavity.
More specifically, Johnson et al teach a layered oral dosage form which comprises a gel layer comprising an active agent or a flavorant. It is disclosed that the dosage form may be a multi-layer product comprising a binder and a gel layer and a carrier medium comprising an active agent. Johnson et al also disclose a method of making the said product which includes needle punching and heating the layers and fibers at suitable temperature ranges as well as suitable weight range for this layered product. Seiler et al teach an oral smokeless product in the form of an oral patch comprising a carrier and an active agent in a nonwoven fiber matrix and in layered structure. Seiler et al also provide guidance on the dimensions of the said patch (strip) and method steps such as web consolidation, including mechanical bonding, e.g. needle punching. Additionally, Mellin et al teach a chewing gum composition in layered structure and a method of making the said product wherein the method steps include mechanical consolidation, needle punching, cutting, packaging, etc. Thus, it would have been obvious to combine the teachings of Mellin et al and Seiler et al with that of Johnson et al to arrive at the claimed invention with a reasonable expectation of success as all references disclose an effective oral dosage form in a layered structure comprising a layer of active agent for the delivery of the said active to the oral cavity of the subject. While Johnson et al do not expressly disclose mechanical consolidation, they do teach needle punching and heating the fibers to attach them together whether by using a binder or using the method of self-bonding.
Regarding the use of application temperatures in claims 18-20, it is noted that Johnson et al teach the use of thermal bonding step and Mellin et al teach heating the fibers to attach them.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying- online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-16, 18-21 and 23-31 of copending Application No. 17/924,174 (US 20230277446) in view of Mellin et al (WO 2022112085) and Johnson et al (US 20210251276). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Mellin et al and Johnson et al.
Examined claim 1 is directed to a product for oral delivery of a substance, the product comprising: a layered structure comprising a plurality of nonwoven fabric layers that include an intermediate carrier layer and a pair of support layers; and a substance held by the intermediate carrier layer. Reference claim 1 recites a chewable product for oral delivery of a substance, the chewable product comprising: a dry-laid carded needled nonwoven fabric substrate having a matrix of interleaved fibers wherein the nonwoven fabric substrate has a thickness of 1-2 mm; and a substance held within the matrix,
The examined claims differ from the reference claims in that they do not explicitly recite a "dry- laid carded" nonwoven fabric substrate having a "thickness of 1-2 mm" wherein the substance is releasable from the matrix by a chewing action as recited in reference claim 1.
Mellin et al however, teach a chewable product for oral delivery of a substance, the chewable product comprising: a nonwoven fabric substrate having a matrix of interleaved fibers; and a substance held within the matrix, wherein the substance is releasable from the matrix by a chewing action and wherein initial web is formed using a dry-laid carding process.
Thus, it would have been obvious to modify the nonwoven fabric substrate of examined claims with the teachings of Mellin et al to form the fiber web using a dry-laid, carded method to form the matrix which is released by chewing. Examined claims 12 and 13 recite an oral product in the form of a tablet or strip wherein the thickness is from 1 to 5 mm, reading on the thickness of the reference claims. Other limitations such as fibers, fiber weight, the binders, etc, are either the same or would have been obvious to modify.
Also, the method steps disclosed in examined claims 14-20 would have been obvious over the method steps in reference claims in view of Mellin et al and Johnson et al. Both sets of examined claims and reference claims include applying, needle punching or looming, cutting, packaging etc. Furthermore, Mellin et al teach the same method steps and Johnson et al teach the step of thermal heating and provides guidance on the temperatures.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8-9, 11-14, and 16-19 of copending Application No. 18/263,777 (US 20240074480) in view of Mellin et al (WO 2022112085) and Johnson et al (US 20210251276). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Mellin et al and Johnson et al.
Examined claim 1 is stated above. Reference claim 1 recites a nonwoven fabric for forming an oral pouched product, the nonwoven fabric comprising a chemically bonded web of staple fibers and a binder and claim 11 recites a method of making the said oral product.
The reference claims differ from the examined claims in that they do not explicitly recite a substance layer in a carrier held in the intermediate layer, or that the method includes mechanical consolidation or needle punching.
Mellin et al however, teach a chewable product for oral delivery of a substance, the chewable product comprising: a nonwoven fabric substrate having a matrix of interleaved fibers; and a substance held within the matrix, wherein the substance is releasable from the matrix by a chewing action and wherein the method of making it includes needle punching and mechanical consolidation, cutting and packaging.
Thus, it would have been obvious to modify the nonwoven fabric substrate of examined claims with the teachings of Mellin et al to form the fiber web using the said method steps with a reasonable expectation of success. Other limitations such as fibers, fiber weight, the binders, etc, are either the same or would have been obvious to modify.
Also, the method steps disclosed in examined claims 14-20 would have been obvious over the method steps in reference claims in view of Mellin et al and Johnson et al. Both sets of examined claims and reference claims include applying, needle punching or looming, cutting, packaging etc. Furthermore, Mellin et al teach the same method steps and Johnson et al teach the step of thermal heating and provides guidance on the temperatures.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights